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510(k) Data Aggregation

    K Number
    K190516
    Device Name
    MicroLink All-Suture Button Fixation System (Radiolucent)
    Manufacturer
    CONMED Corporation
    Date Cleared
    2019-06-28

    (116 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K140328
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CONMED MicroLink™ All-Suture Button Fixation System, when used for fixation of bone-to-bone or soft-issue-to-bone, is intended as a fixation post, distributing suture tension over areas of ligament or tendon repair.

    The CONMED MicroLink All-Suture Button Fixation System is indicated for fixation of bone-to-bone as an adjunct in the following orthopedic surgical procedures:
    Procedure: Carpometacarpal Suspension
    Anatomic Location: Hand

    Device Description

    The MicroLink™ All-Suture Button Fixation System (Radiolucent) is an all-suture suspension device with one strand of #2 (5 metric) Hi-Fi® suture, a radiolucent flat braid Hi-Fi® Suture Button and a radiolucent flat braid Hi-Fi® suture Backstop threaded on a Loader. A suture passing drill is provided with a nitinol loop for passing. A trapezium pin is provided to facilitate manipulation of the trapezium during trapeziectomy. All four catalog numbers are provided sterile, intended for single-use.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria and the study that proves the device meets them in the format requested. The document is a 510(k) summary for the CONMED MicroLink™ All-Suture Button Fixation System (Radiolucent), which focuses on demonstrating substantial equivalence to a predicate device.

    While it mentions "PERFORMANCE DATA" and lists types of testing conducted (e.g., Ultimate Fixation Strength, Cyclic Shear Testing, Biocompatibility), it does not provide:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes used for test sets or training sets.
    • Data provenance (country of origin, retrospective/prospective).
    • Number and qualifications of experts to establish ground truth.
    • Adjudication method.
    • Details of a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
    • Standalone algorithm performance.
    • Type of ground truth used (expert consensus, pathology, outcomes data).
    • How ground truth for the training set was established.

    The document primarily focuses on a comparison of technological characteristics with a predicate device (CMC Mini TightRope) and concludes substantial equivalence based on design, materials, intended use, principles of operation, and technical characteristics, supported by verification and validation testing. However, the specific results against defined acceptance criteria are not detailed in this summary.

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